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Pharmacovigilance - the basics

Medicines - Europe

The learning objectives of this pharmacovigilance training for personnel of European marketing authorization holders include understanding the principles of pharmacovigilance, learning how to identify and report adverse events, and understanding the importance of proactive risk identification and risk minimization. These objectives aim to equip attendees with the knowledge and skills necessary to fulfill their pharmacovigilance responsibilities and ensure the safety and effectiveness of medications.


  • Legal basis
  • Review of the EU-GDP guidelines
  • Principles of Quality Management

For whom

  • All employees and freelancers of marketing authorization holders who may receive safety data related to the marketing authorization holder's medicinal products

no prior knowledge is required

Practical arrangements

  • The training will take ±8 hours
  • Note pages will be available in pdf format
  • Participants who require a training certificate can take a multiple choice quiz (15 items, 80% correct answers to qualify)

A discount is granted from the third participant of the same company.

Please contact us if you would like a customized course for your organization or if you would like the training to be held at your office location.

Course details

Date and time

Quality Systems Made Easy
Jordaenslaan 8
8421 De Haan



€ 1500.00 excluding VAT